Sexual Risk, Substance Use
Conditions
Brief summary
This study will conduct an effectiveness trial of the 4-session evidence-based YMHP intervention for young men who have sex with men (YMSM) of color ages 15-29 at two CBOs in New York City, compared to usual care.
Detailed description
We will conduct a comparative effectiveness trial (CET) with two intensities of treatment to be offered following field-based HIV counseling and testing (C&T) - the young men's health project (YMHP) intervention and an enhanced treatment as usual (eTAU) condition involving HIV prevention services provided at two community based organizations (CBOs) to test their relative effectiveness in reducing substance use and sexual risk behavior among HIV-negative YMSM. In collaboration with two CBOs, our goals are to better understand substance use and sexual health-related outcomes among HIV-negative YMSM who are unlikely to be treatment seeking and to implement the YMHP intervention in a way that will maximize portability and scalability. Working together with our collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce substance use and HIV infection among YMSM.
Interventions
BEHAVIORALYMHP Intervention
BEHAVIORALEnhanced Treatment as Usual
Sponsors
National Institute on Drug Abuse (NIDA)
Hunter College of City University of New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Randomization to YMHP or enhanced Treatment as Usual (eTAU)
Eligibility
Sex/Gender
MALE
Age
15 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* HIV-negative test result from the past 90 days * 15-29 years of age * Born biologically male or currently identifying as male * Sex with men in the past 90 days * ≥ 5 days of illicit drug use in the past 90 days * ≥ 1 episode of condomless anal sex (CAS) in the past 90 days, or a positive sexually transmitted infection test result in the past 90 days. * Living in the New York City area * Able to communicate in English
Exclusion criteria
* Serious cognitive or psychiatric impairments * ≥5 days of injection drug use in the past 90 days * Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Illicit Drug Use Days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month | The self-reported number of illicit drug use days (not including marijuana) in the past 90 days |
| Condomless Anal Sex Acts | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month | The self-reported number of condomless anal sex acts with male partners in the past 90 days |
| Marijuana Use Days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month | The self-reported number of marijuana use days in the past 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month | The self-reported number of alcohol use days in the past 90 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
YMHP Intervention | 47 |
| Enhanced Treatment as Usual The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.
Enhanced Treatment as Usual | 39 |
| Total | 86 |
Baseline characteristics
| Characteristic | Total | Enhanced Treatment as Usual | Intervention |
|---|---|---|---|
| Age, Continuous | 24.4 years STANDARD_DEVIATION 3.3 | 24.3 years STANDARD_DEVIATION 3.21 | 24.5 years STANDARD_DEVIATION 3.37 |
| Education 4-Year College Degree | 13 Participants | 6 Participants | 7 Participants |
| Education Less than 4-Year Degree | 47 Participants | 21 Participants | 26 Participants |
| Education Missing | 26 Participants | 12 Participants | 14 Participants |
| Employment Full-time | 13 Participants | 6 Participants | 7 Participants |
| Employment Missing | 52 Participants | 21 Participants | 31 Participants |
| Employment Part-time | 21 Participants | 12 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 26 Participants | 16 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Latino | 35 Participants | 13 Participants | 22 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 13 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 12 Participants | 6 Participants | 6 Participants |
| Relationship Status Partnered | 24 Participants | 14 Participants | 10 Participants |
| Relationship Status Single | 62 Participants | 25 Participants | 37 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 86 Participants | 39 Participants | 47 Participants |
| Site Study Site 1 | 44 Participants | 11 Participants | 33 Participants |
| Site Study Site 2 | 42 Participants | 28 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 39 |
| other Total, other adverse events | 0 / 47 | 0 / 39 |
| serious Total, serious adverse events | 0 / 47 | 0 / 39 |
Outcome results
Primary
Condomless Anal Sex Acts
The self-reported number of condomless anal sex acts with male partners in the past 90 days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Population: intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Condomless Anal Sex Acts | 9-Months | 12.45 acts | Standard Deviation 15.28 |
| Intervention | Condomless Anal Sex Acts | 3-Months | 9.71 acts | Standard Deviation 17.5 |
| Intervention | Condomless Anal Sex Acts | 12-Months | 7.3 acts | Standard Deviation 10.32 |
| Intervention | Condomless Anal Sex Acts | Baseline | 10.38 acts | Standard Deviation 13.02 |
| Intervention | Condomless Anal Sex Acts | 15-Months | 6.56 acts | Standard Deviation 9.02 |
| Intervention | Condomless Anal Sex Acts | 6-Months | 3.38 acts | Standard Deviation 5.16 |
| Enhanced Treatment as Usual | Condomless Anal Sex Acts | 15-Months | 10 acts | Standard Deviation 11.99 |
| Enhanced Treatment as Usual | Condomless Anal Sex Acts | Baseline | 14.36 acts | Standard Deviation 15.59 |
| Enhanced Treatment as Usual | Condomless Anal Sex Acts | 3-Months | 9.47 acts | Standard Deviation 14.88 |
| Enhanced Treatment as Usual | Condomless Anal Sex Acts | 9-Months | 10.92 acts | Standard Deviation 16.01 |
| Enhanced Treatment as Usual | Condomless Anal Sex Acts | 12-Months | 6.88 acts | Standard Deviation 11.83 |
| Enhanced Treatment as Usual | Condomless Anal Sex Acts | 6-Months | 11.14 acts | Standard Deviation 16.49 |
p-value: 0.9695% CI: [-0.86, 0.99]negative binomial regression
p-value: 0.0395% CI: [-2.25, -0.14]negative binomial regression
p-value: 0.7995% CI: [-0.83, 1.1]negative binomial regression
p-value: 0.9195% CI: [-0.99, 1.11]negative binomial regression
p-value: 0.4495% CI: [-1.5, 0.65]negative binomial regression
Primary
Illicit Drug Use Days
The self-reported number of illicit drug use days (not including marijuana) in the past 90 days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Population: Intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Illicit Drug Use Days | Baseline | 3.04 days | Standard Deviation 7.05 |
| Intervention | Illicit Drug Use Days | 3-Month | 2.00 days | Standard Deviation 5.03 |
| Intervention | Illicit Drug Use Days | 6-Month | 1.19 days | Standard Deviation 2.97 |
| Intervention | Illicit Drug Use Days | 9-Month | 3.81 days | Standard Deviation 8.19 |
| Intervention | Illicit Drug Use Days | 12-Month | 2.00 days | Standard Deviation 4.83 |
| Intervention | Illicit Drug Use Days | 15-Month | 2.08 days | Standard Deviation 5.25 |
| Enhanced Treatment as Usual | Illicit Drug Use Days | 12-Month | 4.35 days | Standard Deviation 11.37 |
| Enhanced Treatment as Usual | Illicit Drug Use Days | Baseline | 11.62 days | Standard Deviation 6.04 |
| Enhanced Treatment as Usual | Illicit Drug Use Days | 9-Month | 3.77 days | Standard Deviation 9.08 |
| Enhanced Treatment as Usual | Illicit Drug Use Days | 3-Month | 6.04 days | Standard Deviation 11.1 |
| Enhanced Treatment as Usual | Illicit Drug Use Days | 15-Month | 6.19 days | Standard Deviation 11.3 |
| Enhanced Treatment as Usual | Illicit Drug Use Days | 6-Month | 6.29 days | Standard Deviation 12.48 |
p-value: 0.1995% CI: [-2.78, 0.56]negative binomial regression
p-value: 0.1295% CI: [-3.78, 0.48]negative binomial regression
p-value: 0.9995% CI: [-2.05, 2.07]negative binomial regression
p-value: 0.4295% CI: [-2.67, 1.11]negative binomial regression
p-value: 0.1895% CI: [-2.69, 0.51]negative binomial regression
Primary
Marijuana Use Days
The self-reported number of marijuana use days in the past 90 days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Population: intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Marijuana Use Days | Baseline | 33.11 days | Standard Deviation 32.59 |
| Intervention | Marijuana Use Days | 3-Months | 34.19 days | Standard Deviation 36.97 |
| Intervention | Marijuana Use Days | 6-Months | 35.81 days | Standard Deviation 39.4 |
| Intervention | Marijuana Use Days | 9-Months | 32.52 days | Standard Deviation 35.26 |
| Intervention | Marijuana Use Days | 12-Months | 37.75 days | Standard Deviation 36.93 |
| Intervention | Marijuana Use Days | 15-Months | 25.08 days | Standard Deviation 32.64 |
| Enhanced Treatment as Usual | Marijuana Use Days | 12-Months | 29.24 days | Standard Deviation 39.22 |
| Enhanced Treatment as Usual | Marijuana Use Days | Baseline | 46.15 days | Standard Deviation 36.14 |
| Enhanced Treatment as Usual | Marijuana Use Days | 9-Months | 42 days | Standard Deviation 39.57 |
| Enhanced Treatment as Usual | Marijuana Use Days | 3-Months | 44.39 days | Standard Deviation 42.45 |
| Enhanced Treatment as Usual | Marijuana Use Days | 15-Months | 36.06 days | Standard Deviation 40.25 |
| Enhanced Treatment as Usual | Marijuana Use Days | 6-Months | 24.50 days | Standard Deviation 32.86 |
p-value: 0.5495% CI: [-1.09, 0.58]negative binomial regression
p-value: 0.4995% CI: [-0.7, 1.46]negative binomial regression
p-value: 0.5995% CI: [-1.18, 0.66]negative binomial regression
p-value: 0.6595% CI: [-0.86, 1.37]negative binomial regression
p-value: 0.4995% CI: [-1.4, 0.67]negative binomial regression
Secondary
Alcohol Use Days
The self-reported number of alcohol use days in the past 90 days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Alcohol Use Days | Baseline | 20.26 days | Standard Deviation 22.15 |
| Intervention | Alcohol Use Days | 3-Months | 18.81 days | Standard Deviation 26.42 |
| Intervention | Alcohol Use Days | 6-Months | 9.94 days | Standard Deviation 11.64 |
| Intervention | Alcohol Use Days | 9-Months | 16.08 days | Standard Deviation 20.98 |
| Intervention | Alcohol Use Days | 12-Months | 14.45 days | Standard Deviation 18.72 |
| Intervention | Alcohol Use Days | 15-Months | 11.35 days | Standard Deviation 14.05 |
| Enhanced Treatment as Usual | Alcohol Use Days | 12-Months | 18.53 days | Standard Deviation 21.16 |
| Enhanced Treatment as Usual | Alcohol Use Days | Baseline | 30.10 days | Standard Deviation 27.14 |
| Enhanced Treatment as Usual | Alcohol Use Days | 9-Months | 27.31 days | Standard Deviation 21.76 |
| Enhanced Treatment as Usual | Alcohol Use Days | 3-Months | 27.04 days | Standard Deviation 28.57 |
| Enhanced Treatment as Usual | Alcohol Use Days | 15-Months | 17.75 days | Standard Deviation 20.52 |
| Enhanced Treatment as Usual | Alcohol Use Days | 6-Months | 20.29 days | Standard Deviation 21.88 |
p-value: 0.31995% CI: [-1.07, 0.34]negative binomial regression
p-value: 0.195% CI: [-1.57, 0.15]negative binomial regression
p-value: 0.295% CI: [-1.34, 0.28]negative binomial regression
p-value: 0.5895% CI: [-1.14, 0.64]negative binomial regression
p-value: 0.3495% CI: [-1.37, 0.47]negative binomial regression